Study type: In vitro · Status: Evidence verified by machine against declared source
The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study.
The journal of headache and pain · 2023
Study scale: A sample size of 10 participants per treatment sequence provided more than 90% power to detect a difference in the AUC of change from the start of infusion of PACAP38 in STA diameter (AUCSTA-PACAP38; primary outcome measure) of 34 mm × min, with a standard deviation of 14 mm × min in the placebo + PACAP38 + VIP treatment sequence and a standard deviation of 4 mm × min in the Lu AG09222 + PACAP38 + VIP treatment sequence, at a two-sided 5% significance level.
Abstract only: Open source record
Product or molecular entity relationships
- VIP: Exact entity relationship. Legacy citation custody associates this source with the catalog record; no product-relevance conclusion is implied.
Public plain-language summary
Some fields are not published, because the text held for them did not answer their heading. The published text is limited to the declared source and preserves reported uncertainty. It does not establish efficacy, safety, suitability, or evidence strength.
Research question
Our objective was to determine whether Lu AG09222, an investigational humanized monoclonal antibody directed against PACAP ligand, would inhibit the PACAP-signaling cascade by abolishing its vasodilatory and headache-inducing abilities.
Study design
In a randomized, double-blind, parallel-group, single-dose, placebo-controlled study of Lu AG09222, healthy volunteers aged 18–45 years without history of headache disorders were randomly allocated to three treatment sequences (1:2:2) on two experimental infusion visits with 9 ± 3 days’ interval: placebo + saline + saline (n = 5), placebo + PACAP38 + VIP (n = 10), and Lu AG09222 + PACAP38 + VIP (n = 10).
Participants or experimental system
Not published. The text held for this field did not answer this heading, so nothing is shown here and nothing is substituted for it.
Study scale
A sample size of 10 participants per treatment sequence provided more than 90% power to detect a difference in the AUC of change from the start of infusion of PACAP38 in STA diameter (AUCSTA-PACAP38; primary outcome measure) of 34 mm × min, with a standard deviation of 14 mm × min in the placebo + PACAP38 + VIP treatment sequence and a standard deviation of 4 mm × min in the Lu AG09222 + PACAP38 + VIP treatment sequence, at a two-sided 5% significance level.
Intervention or exposure
The primary outcome measure was area under the curve (AUC) of the change in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38.
Comparator
This proof-of-mechanism randomized controlled trial investigated the effect of Lu AG09222 on vascular responses and headache after PACAP38 and VIP infusion in healthy volunteers.
Outcomes examined
Not published. The text held for this field did not answer this heading, so nothing is shown here and nothing is substituted for it.
Key findings
In participants who received Lu AG09222 + PACAP38 infusion, there was a significantly lower STA diameter (mean (SE) [95% CI] AUC ‒35.4 (4.32) [‒44.6, ‒26.3] mm × min; P < 0.0001) compared to participants who received placebo + PACAP38 infusion.
Limitations and uncertainty
Not published. The text held for this field did not answer this heading, so nothing is shown here and nothing is substituted for it.
Product relevance and evidence boundary
This record is a published study, held here with its citation and review status. It is not a statement that any catalog item is effective, safe, or suitable for any use, and nothing in it is a dose or a protocol.
Evidence verified by machine against declared source. Verification is limited to the declared source and review scope. It does not mean independent replication or establish efficacy, safety, or suitability.